Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting
Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the
inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death,
occurred in cases where a tip separation

FDA DeterminedCause 2

PRODUCTION CONTROLS: Process Control

Action

Cook Medical sent an Urgent Medical Device Recall letter dated April 24, 2013 to all affect customers. The letter identified the affected products, description of the problem, and actions to be taken. The letter instructed customers to stop use, quarantine, and return all affected products. Customers were asked to complete product reply form and return affected products for credit to Cook Medical, ATTN: Retrun Goods/RGA # 2013C0003. For questions contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235.